Kornimate/medical-research-clean huggingface dataset:
hypofractionated brain radiationcavity

Conditions: Brain Metastases, Adult; Cancer Brain

Summary: stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. the standard whole-brain radiotherapy (wbrt) demonstrated to reduce the risk of recurrence without improving survival. at the same time wbrt have substantial acute and late toxicity. preliminary experiences with stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. this attitude was only partially explored in prospective trials. in this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (primary endpoint) by repeated mri and of quality of life, neurologic functionning (with a battery of thsts, e.g. mmse, qlq-c30, eortc bn-20) as well as overall survival as secondary endpoints.

Eligibility criteria:
inclusion criteria: * patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with srs / igrt of the surgical cavity * patient ≥ 18 years * willngness to participate in the study, written informed consent * performance status according to who 0-i * good general conditions and organ function * newly diagnosed chemotherapy-naïve disease or controlled systemic disease * good bone marrow, renal and hepatic function * stable steroid dose or reduced for at least 5 days exclusion criteria: * history of previous brain irradiation * pregnancy or breastfeeding * histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy

Keywords: radation therapy sterotactic radiosurgery quality of life solid cancer palliation neurologic functionning
gut microbiota in metabolic surgery

Conditions: Bariatric Surgery Candidate; Cardiovascular Diseases; Type 2 Diabetes; Dyslipidemias; Hypertension; Morbid Obesity

Summary: metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (cvd). metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. furthermore, few studies have included african americans, a population with high rates of cardiometabolic diseases. the investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. in the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at vanderbilt university medical center and follow them for up to 10 years after surgery. fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. meanwhile, participants will complete a redcap survey at baseline and 1-year, 2-year, and 3-year post-surgery. participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. the investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. this study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.


Eligibility criteria:
inclusion criteria: * be approved and scheduled for metabolic surgery at the vanderbilt university medical center * have a history of type 2 diabetes, hypertension, or dyslipidemia * be able and willing to provide personal information and biological samples needed for the study exclusion criteria: * prior gastric operations * a history of coronary artery disease, stroke, heart failure, hiv infection, or untreated viral hepatitis * chemotherapy or radiotherapy for cancer within 2 years * current inflammatory bowel disease or celiac disease * vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months
noninvasive respiratory support in covid-19 (catcovid-air)

Conditions: Covid19; Acute Respiratory Failure; Corona Virus Infection

Summary: covid-19 pneumonia can cause severe acute hypoxemic respiratory failure. the usefulness of noninvasive respiratory support (nirs), by means of nasal high-flow oxygen (nhfo), continuous positive airway pressure (cpap), or noninvasive ventilation (niv), established outside the intensive care unit, is unknown. the aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.

multicenter, retrospective, longitudinal study in consecutive adult covid-19 patients with acute respiratory failure, requiring noninvasive respiratory support (nirs) outside the intensive care unit (icu) in 10 hospitals in catalonia (spain). demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section). during the hospitalization, patients were treated according to the standard procedures of the participating centers. this study is observational and no randomization have been performed. patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from nirs initiation.

Eligibility criteria:
inclusion criteria: * covid-19 pneumonia confirmed with polymerase chain reaction (pcr). * acute respiratory failure. * treated by noninvasive respiratory support (nasal high-flow oxygen, cpap or noninvasive ventilation), initiated outside the intensive care unit. * age \> 18 years exclusion criteria: * acute respiratory failure not related to covid-19 * hypercapnic acute respiratory failure * early intolerance to treatment * nosocomial infection * pregnant woman

Keywords: noninvasive ventilation high-flow nasal cannula severe acute respiratory syndrome respiratory failure respiratory tract diseases coronavirus infection
density of neurons in the stomach and prognosis of gastric adenocarcinoma

Conditions: Stomach Neoplasms

Summary: preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. the data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. gene expression data indicate that vagotomy suppresses protein gene product 9.5 (pgp9.5). the expression of pgp9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. the investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the department of gastrointestinal surgery, st olavs hospital, trondheim university hospital. the biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of pgp9.5. these data will be correlated to stage evaluation (tnm) and survival.


Eligibility criteria:
inclusion criteria: * fifteen patients evaluated- or treated for suspected or verified gastric adenocarcinoma at the department of gastrointestinal surgery, st olavs hospital, trondheim university hospital * informed consent exclusion criteria: * general contraindications for endoscopy with biopsies (i.e. bleeding disorders or use of anticoagulants).

Keywords: tumor markers, biological pgp9.5 protein, human adenocarcinoma
study of remodulin in patients with critical limb ischemia with no planned revascularization procedures

Conditions: Critical Limb Ischemia; Peripheral Vascular Disease; Foot Ulcers; Rest Leg Pain

Summary: the purpose of this study is to assess and compare the safety of continuous and daily subcutaneous remodulin therapy in patients with critical limb ischemia (cli) with no planned vascular interventional procedures; and to determine the effect of remodulin on wound healing and treadmill walk distance.


Eligibility criteria:
patients with stage iii or iv critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Keywords: critical limb ischemia peripheral vascular disease ut-15 remodulin treprostinil
evaluation of the pharmacokinetics and safety of inaxaplin in participants with mild or moderate hepatic impairment

Conditions: Focal Segmental Glomerulosclerosis (FSGS)

Summary: the purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of inaxaplin (ixp) in participants with mild or moderate hepatic impairment and in matched healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * cohorts 1 and 3: participants with hepatic impairment * cohort 1 (mild impairment): defined as a child-pugh total score of 5 to 6 (child-pugh class a) * cohort 3 (moderate impairment): defined as a child-pugh total score of 7 to 9 (child-pugh class b) * cohorts 2 and 4: healthy participants * participants will be matched during screening to participants with mild (cohort 1) or moderate (cohort 3) hepatic impairment according to each of the following parameters: age (± 10 years); sex; and bmi (± 15%) key exclusion criteria: * cohorts 1 and 3: participants with hepatic impairment * acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug * participants who smoke * cohorts 2 and 4: healthy participants * acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply
phase 3 28-week study with 24-week and 52-week extension phases to evaluate efficacy and safety of exenatide once weekly and dapagliflozin versus exenatide and dapagliflozin matching placebo

Conditions: Diabetes Mellitus

Summary: study d5553c0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (eqw) 2 mg and dapagliflozin 10 mg once daily (qd) compared to eqw 2 mg alone and dapagliflozin 10 mg qd alone in patients with type 2 diabetes who have inadequate glycemic control on metformin.


Eligibility criteria:
inclusion criteria * has a diagnosis of t2dm. * has hba1c of 8.0% to 12.0%, inclusive, at visit 1 and visit 2. * treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to screening. exclusion criteria * fpg ≥280 mg/dl (15.6 mmol/l). * serum calcitonin concentration ≥40 pg/ml (≥40 ng/l) at visit 1 (screening) * clinically significant abnormal free t4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator. * abnormal thyroid stimulating hormone (tsh) value at screening will be further evaluated by free t4.patients with clinically significant abnormal free t4 values will be excluded. * known active proliferative retinopathy. * history of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dl (≥5.65 mmol/l) at visit 1 * history or presence of inflammatory bowel disease or other severe gi diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis. * history of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. current use of gastric balloons is also excluded.

Keywords: diabetes mellitus exenatide dapagliflozin diabetes medication treatment efficacy placebo metabolism cardiovascular metabolic
assessment of grasp medical device to improve arm coordination after stroke

Conditions: Stroke

Summary: assessment of a custom made grasp device in the rehabilitation of stroke victims.


Eligibility criteria:
inclusion criteria: 1. damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by ct scan: parietal, cerebellar, internal capsule and basal ganglia, 2. a score of 6 or more on the arm section of the rivermead motor assessment (able to reach and pick up a tennis ball and release on thigh), 3. time between start of hand opening and start of hand transport \> 60 ms (measured with grasp). exclusion criteria: 1. cognitive dysfunction which prevents understanding of the task, 2. severe concurrent medical problems that prevent repetitive reaching (including shoulder pain), 3. a diagnosis of parkinson's disease, or 4. lack of informed consent.
retigabine (adjunctive therapy) efficacy and safety study for partial onset refractory seizures in epilepsy

Conditions: Seizures

Summary: this phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (aeds).

this phase 3 study is being conducted in north america, argentina, and brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (aeds). the primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. the proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization * 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase * currently treated with up to three established aeds * vagal nerve stimulator may be included exclusion criteria: * existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study * clinically significant abnormalities on physical exam, vital signs, ecg, or liver function tests * impaired renal function (creatinine clearance less than 50 ml/minute) * evidence of progressive central nervous disease, lesion, or encephalopathy * history of primary generalized seizures * history of clustering or flurries or status epilepticus within 12 months of study entry

Keywords: partial seizures anticonvulsant complex partial seizures potassium channels epilepsy
magnetic resonance imaging (mri) characterization of carotid plaque and prediction of end-organ and clinical outcomes

Conditions: Atherosclerosis; Carotid Artery Disease

Summary: the canadian atherosclerosis imaging network (cain) is a pan-canadian imaging network funded through grants from the canadian foundation for innovation (cfi) and the canadian institutes of health research (cihr). this unique research network is focused on the pathobiology of atherosclerotic disease as it pertains to the coronary and carotid circulations. the cain research program involves the creation of a unique national network focused on in vivo imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as the acquisition of clinical and pathological end points. cain enables unprecedented cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in coronary or carotid vascular beds, and has established an international resource for studying the natural history, progression, regression and novel therapeutic interventions aimed at atherosclerosis. the primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe (30-95%) carotid disease. the investigators will also assess evidence of ischaemic brain disease. patients will undergo mri scanning of the brain and carotid and us scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease. patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of clinical and imaging data. after each imaging session images will be processed, stored locally and also sent to a central repository. 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years.


Eligibility criteria:
inclusion criteria: * male and female patients over the age of 18 years. * written informed consent (approved by the institutional review board \[irb\]/independent ethics committee \[iec\]) obtained prior to any study specific procedures. * patient with mild to severe carotid artery disease exclusion criteria: * any condition that would contra-indicate magnetic resonance imaging or administration of contrast agent
electrogram and hemodynamic characteristics of adaptive lbbap in patients with heart failure or bradycardia

Conditions: Cardiac Pacing; Pacing Therapy

Summary: this is a multi-site, non-randomized, data collection study. the purpose of this study is to investigate the cardiac electrical and mechanical function during lbbap with different av intervals.

left bundle branch pacing (lbbp), achieved via trans-septal approach with the pacing tip at the left side of the ventricular septum, has recently initiated and been well practiced in china. lbbp is characterized with relatively ease of implantation (usually \<5 minutes fluoroscopic use time), narrow paced qrs duration (similar to physiological pacing), low and stable pacing threshold (usually around 0.5v @0.5ms, good for device longevity and long-term stability without need of back-up pacing lead), high r wave amplitude for pacing management, and lbbb (left bundle branch block) correction by a low pacing output. lbbap (left bundle branch area pacing) can generate a relatively narrow qrsd and fast left ventricular activation. as av interval is an important pacing parameter relevant to cardiac function. this study is to investigate the cardiac electrical and mechanical function during lbbap with different av intervals.

Eligibility criteria:
inclusion criteria: * patients aged from 18 to 80 years old * patients who are willing to provide informed consent * patients who received lbbap for at least 3 months * patients' implanted device can provide intracardiac electrograms * bradycardia patients with avb or heart failure patients with lbbb exclusion criteria: * patients who are pregnant or have a plan for pregnancy during the study * patients with persistent af * patients who have medical conditions that would limit study participation * patients who were already enrolled in other clinical trial which would impact his/her participation
assessing the impact of a call center providing standardized pediatric advice (platel-eval)

Conditions: Emergency Pediatric Care

Summary: in order to show that tailored pediatric counselling by telephone can reduce the number of unscheduled and medically unjustified physicians visits in emergency structures, a randomized controlled study is conducted. it compares the proportion of cases which used the emergency services or unscheduled consultation according to whether they received (or not) nurses' telephone advices from the platform. indeed, our hypothesis is that the presence of nurses responding at the reception and control calls center inside the emergency medical services (in french : service d'aide médicale d'urgence samu) - whose role is to deliver appropriate advice to people calling for benign pathologies they see as urgent and to answer questions following specific recommendations - will reduce the number of unplanned and medically unjustified consultations in medical emergency structures. this platform was set-up in order to show it may be a solution in response to the growing demand for pediatric care from the population, helping to reduce overcrowding in emergency care facilities. indeed, promoting home care or only if necessary scheduled consultation reinforces the conduct to have when facing a pathology from their child. it will also help by reducing unjustified use of emergency structures, improving not only the users' reception conditions who actually require support in these structures with less waiting time, but also the working conditions for employees who perform there.


Eligibility criteria:
inclusion criteria: * the inclusion criteria are different depending on the subject concerned, for reasons related to risk factors of pediatric diseases. they are audited by the regulator doctor (who has a fact sheet) and are controlled by the nurse of the platform. * for fever theme, a call is eligible if the child is older than 3 months and under 6 years old, and has had a fever for less than 48 hours. * for the theme diarrhea, a call is eligible if the child in question is aged from 12 months to 3 years, and has had diarrhea. fever and vomiting are not exclusion criteria. * for the theme breathing difficulty, a call is eligible if the child in question is aged from 3 months to 3 years, has experienced discomfort breathing and has shown no fever. stuffy nose, runny nose and cough are not exclusion criteria. * for the theme fall with head shock, a call is eligible if the child concerned is a toddler and until the age of 12. * for the theme crying infant, a call is eligible if the child in question is aged 0-4 months and has been crying. fever is an exclusion criterion. exclusion criteria: * refusal of participation or refusal to be reminded to 7 days, * children with impaired general condition and / or behavior change during the call, * situation requiring medical attention without delay, * lack of understanding of the caller

Keywords: call center nurses pediatrics standardized messages family counseling